Class 2 Device Recall CryoValve

• Date Initiated by Firm: March 19, 2003
• Date Posted: April 15, 2003
• Recall Status: Terminated on May 05, 2003
• Recall Number: Z-0723-03
• Recall Event ID: 25832
• Product Classification: unknown device name - Product Code LMO
• Product: CryoValve Heart-valve, allograft
• Code Information: Aortic Valve & Conduit, Donor #34695, Serial #6356206, Model #AV00 and Pulmonary Valve & Conduit, Donor #34695, Serial #6356214, Model #PV00.
• FEI Number: 3001451326
• Recalling Firm/ Manufacturer: Cryolife Inc; 1655 Roberts Blvd Nw; Kennesaw GA 30144
• For Additional Information Contact: Shari L. Allen; 770-419-3355
• Manufacturer Reason for Recall: The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
• FDA Determined Cause: Other
• Action: Implanting physicians were notified by letter on 3/19/2003. Since CryoLife has been notified that the allografts have been implanted, the notification is intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. They were advised to complete an enclosed, stamped, self-addressed postcard to affirm receipt of the notification.
• Quantity in Commerce: There are two individual heart valve allografts.
• Distribution: Allografts were distributed to 2 physicians in NY and MS. Allografts were implanted.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.